Needleless valve for use in intravenous infusion

ABSTRACT

An IV port body defining an IV port includes a valve body configured as a luer fitting, and a movable valve member defining an outer periphery that is uninterrupted within the periphery is disposed in the valve body. The valve member is biased to a first configuration, wherein a passageway for fluid communication is not established through the valve body. Also, the valve member can be moved to a second configuration, wherein fluid communication through the body is permitted.

RELATED APPLICATIONS

The present application is a continuation of and claims priority fromU.S. patent application Ser, No. 08/612,875, now U.S. Pat. No.5,645,538, for an invention entitled "Needleless Valve for use inIntravenous Infusion" filed March 12, 1996, which in turn is acontinuation-in-part of Ser. No. 08/123,632 U.S. Letters Pat. No.5,405,333, filed on Sep. 16, 1993 for an invention entitled "LiquidMedicament Bag With Needleless Connector Fitting Using Boat Assembly"which in turn is a continuation-in-part of Ser. 07/997,610 U.S. Pat. No.5,391,150, filed on Dec. 28, 1992 for an invention entitled "IV Bag WithNeedleless Connector Ports."

FIELD OF THE INVENTION

The present invention relates generally to intravenous liquid medicamentinfusion equipment, and more particularly to needleless valves for usetherein.

BACKGROUND OF THE INVENTION

One of the most widely used methods of medical therapy is theintravenous (IV) infusion of medicaments and/or nutrients into thebloodstream of a patient. Commonly, syringes or IV containers, such asbags, having at least one opening are used to hold the fluid to beinfused. Many IV containers can have more than a single opening, toestablish both a pathway for extracting fluid from the container and apathway for injecting fluid into the container. The openings can beformed in the bottom seam of the container or in the side of thecontainer, and the openings are blocked by membranes.

Ordinarily, to establish fluid flow through the opening the membrane ispierced by inserting a so-called IV spike into the opening. The spike isusually connected to a transparent drip chamber for visually verifyingfluid flow and flow rate from the container (e.g., a bag), and the dripchamber in turn is connected to an IV line to the patient.Alternatively, a resealable membrane can cover one of the openings, andthe resealable membrane can be punctured by the needle of a syringe toinject additional fluid from the syringe into the bag.

It has become apparent, however, that the use of "sharps" such asneedles and spikes raises the possibility that a health care workercould inadvertently puncture the container/bag or himself with theneedle or spike, and thus increase the risk of transmitting tragicdiseases such as AIDS. Thus, the use of needles and other "sharps"should be avoided whenever possible in the health care environment.

Further, even though a spike may not necessarily be considered a "sharp"under all circumstances, the existing membrane arrangements requiringthe use of a spike do not permit removal of the spike from the container(bag) until the contents of the bag are completely exhausted. This isbecause the hole a spike makes in a membrane is typically too large topermit the membrane to reseal. Thus, once inserted, a spike is notusually removed from an IV bag until the bag is empty, which canunderstandably limit use of the bag and its contents.

Accordingly, it is an object of the present invention to provide aneedleless valve for use with IV components. Another object of thepresent invention is to provide a spikeless/needleless valve incombination with various IV components and configurations. Yet anotherobject of the present invention is to provide a spikeless/needleless IVvalve that is easy to use and cost-effective to manufacture.

SUMMARY OF THE INVENTION

A device for holding liquid medicament includes an IV component havingan opening formed therein. A valve including a valve body is operablyengaged with the opening, and the valve has a first position, wherein apassageway for fluid communication is established through the opening,and a second position, wherein fluid communication through the openingis not permitted. In accordance with the present invention, the valveincludes a male valve element having a skirt disposed within the valvebody and an engagement surface extending outwardly beyond the valve bodyfor contacting a spikeless/needleless connector to cause the valveelement to reciprocate relative to the IV component. The valve is biasedto the second position and is engageable with the spikeless/needlelessconnector to establish the first position of the valve.

Preferably, the IV component is a component selected from the group ofcomponents consisting of: IV containers and bags, syringes, spikes,fluid lines, drip chambers, connector fittings, filters, Burettechambers, stopcocks, and multiport valves.

In another aspect of the present invention, a valve includes a hollowbody defining a fluid passageway therethrough, and a resilient valvedisc is positioned in the fluid passageway. The disc is biased to aclosed configuration, wherein the disc blocks fluid flow through thefluid passageway, and the disc is movable to an open configuration,wherein fluid flow is permitted through the fluid passageway. Further,the valve includes a male valve element which is formed with a skirt andan engagement surface extending outwardly from the fluid passageway forcontacting a spikeless/needleless connector. The spikeless/needlelessconnector can be advanced against the valve element to urge the valveelement against the valve disc and thereby move the valve disc to theopen configuration.

These and other aspects of the present invention can best be appreciatedin reference to the accompanying drawings in which like numerals referto like parts, and in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the IV bag of the present invention,shown in one intended environment;

FIG. 1A is a perspective view of a glass vial with reflex valve;

FIG. 2A is a cross-sectional view of one of the valves of the IV bag, asseen along the line 2--2 in FIG. 1, with the valve in the closedposition;

FIG. 2B is a cross-sectional view of one of the valves of the IV bag, aswould be seen along the line 2--2 in FIG. 1, with the valve in the openposition;

FIG. 3 is an exploded view of the valve shown in FIG. 2A, with portionsof the tamper-proof cap broken away, or shown in phantom for clarity;

FIG. 4A is a cross-sectional view of another one of the valves of the IVbag, as seen along the line 2--2 in FIG. 1, with the valve in the closedposition;

FIG. 4B is a cross-sectional view as would seen along the line 2--2 inFIG. 1, with the valve in the open position;

FIG. 5 is a perspective view of a liquid medicament bag having a maleand a female reflex valve, with portions of the bag broken away;

FIG. 6 is a cross-sectional view of the liquid medicament bag of thepresent invention, as seen along the line 6--6 in FIG. 5;

FIG. 7 is a cross-sectional view of the liquid medicament bag of thepresent invention, as seen along the line 7--7 in FIG. 5, with the valvein the closed configuration;

FIG. 8 is a cross-sectional view of the liquid medicament bag of thepresent invention, as would be seen along the line 7--7 in FIG. 5, witha female luer fitting shown in phantom engaging the valve, with thevalve in the open configuration;

FIG. 9 is a perspective view of an alternate embodiment of the valveassembly for the liquid medicament bag of the present invention;

FIG. 10 is a perspective view of another alternate embodiment of theliquid medicament bag of the present invention, with thetamper-resistant caps shown in an exploded relationship with theirrespective valves;

FIG. 11 is an exploded cross-sectional view of yet another alternateembodiment of the liquid medicament bag of the present invention;

FIG. 12 is an exploded cross-sectional view of still another alternateembodiment of the liquid medicament bag of the present invention, withportions broken away, showing a valve of the present invention connectedto a medicament bag by a luer fitting;

FIG. 13 is an exploded cross-sectional view of another alternateembodiment of the liquid medicament bag of the present invention, withportions broken away, showing a valve of the present invention connectedto a medicament bag by a tubular connector;

FIG. 14 is a cross-sectional view of a male reflux valve of the presentinvention shown disposed in a male Luer fitting, with portions brokenaway for clarity;

FIG. 15 is a cross-sectional view of a male reflux valve disposed in amale Luer fitting which has been coaxially bonded to a female Luerfitting;

FIG. 16 is a cross-sectional view of a male Luer fitting with malereflux valve bonded to an annular fitting;

FIG. 17 is a cross-sectional view of a male Luer fitting with malereflux valve in combination with a check valve;

FIG. 18 is a cross-sectional view of a male Luer fitting with malereflux valve bonded to a barbed connector;

FIG. 19 is a cross-sectional view of a male Luer fitting with malereflux valve bonded to a stepped connector;

FIG. 20 is an enlarged cross-sectional view showing a valve element ofthe present invention having an angled contact surface;

FIG. 21 is a cross-sectional view of a male Luer fitting with malereflux valve bonded to a threaded connector;

FIG. 22 is a cross-sectional view of a male Luer fitting with malereflux valve bonded to a "T"-site connector;

FIG. 23 is a cross-sectional view of a male Luer fitting with malereflux valve bonded to a "Y"-site connector;

FIG. 24 is an exploded cross-sectional view showing a male Luer fittingand male reflux valve and a female Luer fitting with female reflux valvein combination with two types of syringes;

FIG. 25 is an exploded partial cross-sectional view of various refluxvalves in combination with a drip chamber and a Burette chamber;

FIG. 26 is a cross-sectional view of a male Luer fitting with malereflux valve and female Luer fitting with female reflux valve bonded toa Burette chamber;

FIG. 27 is a plan view of a plurality of Luer fittings with refluxvalves operably engaged with a stopcock;

FIG. 28 is an exploded plan view of various reflux valves in operableengagement with various types of spikes;

FIG. 29 is an exploded isometric view of a four-way valve with variousassociated components including Luer fittings with reflux valves;

FIG. 30 is an exploded isometric view of an in-line multiport valveassembly;

FIG. 31 is a cross-sectional view of a male reflux valve in operableengagement with a tapered adapter fitting; and

FIG. 32 is a cross-sectional view of a male reflux valve of the presentinvention in operable engagement with an enteral fitting.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring initially to FIG. 1, an intravenous (IV) infusion container,configured for purposes of disclosure as a bag, is shown and generallydesignated 10. Preferably the bag 10 is made of a suitable inert,biocompatible, flexible material, such as polyvinylchloride (PVC) orplex dr. It is to be understood, however, that the principles of thepresent invention can be applied to other types of IV fluid containers,such as semi-rigid containers (not shown), multi-layer bags for holdingcell culture (FIG. 6), or glass bottles and vials (FIG. 5).

As shown in FIG. 1, the bag 10 holds a fluid 12 to be infused into apatient 14 through IV line 16. It is to be understood that the IV line16 may be operably engaged with respective devices, such as rollerclamps (not shown) for selectively permitting fluid communicationthrough the IV line 16.

FIG. 1 shows that the IV line 16 is connected to a conventional dripchamber 20, and the drip chamber 20 is in turn connected to aconventional spike 22. The spike 22 is engaged with a conventional port24 of the bag 10. As shown in FIG. 1, the port 24 is essentially a tubethat has a first end inserted into an opening in the IV bag 10 at thebottom seam 26 of the IV bag 10. The conventional port 24 has a membrane(not shown) positioned therein, and the spike 22 pierces the membrane toestablish a path for fluid communication between the spike and theinterior of the IV bag.

Still referring to FIG. 1, the bag 10 also has a spikeless/needlelessport 28 that includes a tube which is inserted into an opening in thebottom seam 26 of the bag 10 and then bonded by means well-known in theart (e.g., ultra-sonic welding, solvent bonding, heat staking, spinwelding or rf sealing). Alternatively, the tube of the port 28 can beformed integrally with the IV bag 10, or the tube can be bondedinternally to the bag 10.

FIG. 1 further shows that the port 28 includes a valve 30 which isconfigured as a female luer fitting. A needleless syringe 32 can beoperably engaged with the spikeless/needleless port 28. Preferably, theneedleless syringe 32 has an end 34 configured as a male luer fitting,to facilitate engagement of the syringe 32 with the spikeless/needlelessport 28. The syringe 32 can be used to inject additional fluid into thebag 10. Alternatively, a blunt spike (not shown) having an endconfigured as a male luer fitting can be engaged with thespikeless/needleless port 28 to establish a passageway for fluidinfusion from the bag 10 into an IV line (not shown) and thence into thepatient 14.

While FIG. 1 shows a spikeless/needleless port 28 and a conventionalport 24, it is to be understood that additional spikeless/needlelessports (not shown) can be included in the bag 10. It is to be furtherunderstood that the conventional port 24 can be omitted from the bag 10,or additional conventional ports Knot shown) included in the bag 10. Inany case, the ports 24, 28 that extend from the bottom seam 26 of thebag 10 can be formed integrally with the bag 10 or attached to the bag10 by well-known means, e.g., by rf sealing, ultrasonic welding, heatstaking, spin welding, or solvent bonding.

In addition to the ports 24, 28 that extend from the bottom seam 26 ofthe bag 10, FIG. 1 shows that another port 36, colloquially known as a"belly button," can be formed in a side surface 38 of the bag 10.Preferably, the belly button port 36 incudes an opening in the sidesurface 38 of the bag 10, and a valve 42 is disposed in the opening. Aneedleless syringe (not shown), e.g., a syringe having a male luerfitting in lieu of a sharp needle, can be engaged with the belly buttonport 36 to inject or extract fluid from the bag 10.

Now referring to FIG. 2A, the details of the spikeless/needleless port28 can be seen. As shown, the spikeless/needleless port 28 includes ahollow tube 44, and the valve 30 is positioned in the tube 44 toselectively prevent fluid communication through the tube 44. The valve30 includes a rigid, preferably plastic (e.g., PVC) valve body 46 thathas a fluid inlet 48, a fluid outlet 50, and a fluid passageway 52formed in the valve body 46 between the inlet 48 and outlet 50. Thevalve body 46 can be a unitary structure, or be made of two or morepieces that are bonded together, as shown. For example, the inlet 48 canbe formed from a first piece 49, the outlet 50 can be formed from asecond piece 51, and the two pieces can be bonded together by meanswell-known in the art, e.g., solvent bonding, ultrasonic sealing, or rfwelding.

In cross-reference to FIGS. 2A and 3, the valve 30 also includes valvemember 54 that is disposed in the fluid passageway 52. Specifically, theperiphery of the valve member 54 rests on a seating surface 56 of thevalve body 46 to establish a fluid-tight seal between the valve member54 and seating surface 46. In other words, the valve member 54 is biasedto the closed configuration shown in FIG. 2A. A support element 58 isformed in the fluid passageway 52 and extends across the fluidpassageway 52.

The support element 58 supports the valve member 54 in the centerthereof. To this end, a slight depression may be formed in the center ofthe valve member 54 to receive the support element 58 and therebyprevent side-to-side motion of the valve member 54 relative to thesupport element 58. As shown, the support element 58 is shaped as acylinder, but it is to be understood that the support element 58 canhave other suitable shapes, e.g., the support element 58 can have atriangular shape.

Additionally, a retainer element 60 is formed on the valve body 46 andextends across the fluid passageway 52. As shown, the retainer element60 is positioned on the valve body 46 on the opposite side of the valvemember 54 from the support element 58. Accordingly, the retainer element60 holds the center of the valve member 54 against the support element58.

Still referring to FIGS. 2A and 3, a rigid urging member 62 is shownslidably disposed in the fluid passageway 52 for reciprocal movementtherein. As shown, the urging member 62 has an annular head 64 and askirt 66 that depends from the head 64. As further shown, the skirt 66includes a plurality of, preferably two, legs. The urging member 62 canbe forced against the valve member 54 by advancing an appropriateconnector fitting (not shown), such as a male luer fitting, into thefluid passageway 52 and against the urging member 62.

As shown in FIG. 2B, when the urging member 62 is forced against thevalve member 54, the skirt 66 of the urging member 62 contacts thesurface of the valve member 54. This deforms the valve member 54,causing the sealing surface of the valve member 54 to be distanced fromthe seating surface 56 of the valve body 46, and thereby permittingfluid communication through the fluid passageway 52. Stated differently,a spikeless/needleless connector can be advanced into the fluidpassageway 52 to force the urging member 62 against the valve member 54and deform the valve member 54 into an open configuration. When thespikeless/needleless connector is retracted from the fluid passageway52, the resiliency of the valve member 54 causes the valve member 54 toresume its normally closed configuration, shown in FIG. 2A.

Referring back to FIG. 3, a tamper-resistant cap 84 can be engaged withthe valve 30. In one presently preferred embodiment, a skirt 85 of thecap 84 has a plurality of resilient ratchet threads 86. The ratchetthreads 86 are configured generally as right triangles, as shown, andpermit rotation of the cap 84 in the clockwise direction relative to thevalve 30 to thereby engage the cap 84 with the valve 30. The threads 86do not, however, permit easy rotation of the cap 84 in the counterclockwise direction. The threads 86 ratchetably engage blades 87 thatare formed on the first piece 49. It is to be understood that the cap 84can engage any appropriate surface of the first piece 49 or otherappropriate surface of the valve 30.

FIGS. 4A and 4B show that the valve 42 is, in all essential respects,identical to the valve 30. Specifically, the valve 42 has a valve body68 forming a fluid passageway 70. A valve member 72 is positioned in thefluid passageway 70 for selectively blocking fluid communicationtherethrough. An urging member 74 is disposed in the fluid passageway 70for reciprocal movement therein, and a spikeless/needleless connector(not shown) can be advanced into the fluid passageway 70 against theurging member 74 to open the valve 42.

Cylindrical or pyramidal protrusions 42a can be formed on the valve 42for preventing a vacuum lock between the valve member 118 and the firstflange 40. Alternatively, grooves (not shown) could be formed in thevalve body 68 for preventing a vacuum lock between the valve member 72and the valve body 68.

The valve 42 is attached, as by solvent bonding, spin welding, rfwelding, or ultrasonic sealing, to the side 38 of the bag 10. An opening76 is formed in the side 38 of the bag 10, for establishing a pathwayfor fluid communication into and out of the bag 10. Alternatively, anopening (not shown) can be formed in the top or bottom seam of the bag10, and additional openings (not shown) can be formed in the bag 10.

The opening 76 can be formed in the side 38 of the bag 10 duringmanufacture of the bag 10 by cutting out a portion of the bag 10. Morepreferably, a die cut is made in the side 38 of the bag 10 in apartially circular pattern to form a flap 78. The flap 78 remainsattached to the bag 10 by an uncut nick 80, and a protrusion 82 isformed on the valve 42 for urging against the flap 78 to unblock theopening 76 when the valve 42 is attached to the bag 10. Thereby, theflap 78 does not prevent fluid flow through the opening 76, once thevalve 42 is in place, and the flap 78 does not become detached from thebag 10. This ensures that the flap 78 will not enter the fluid in thebag 10 and thus will not foul any of the IV components valve memberdiscussed above. Alternatively, the flap 78 can be separated from thebag 10 during manufacturing, and the protrusion 82 omitted from thevalve 42.

Specifically, to disengage the cap 84 from the valve 30, sufficienttorque must be imparted to the cap 84 to strip to ratchet threads 86.Consequently, once the cap 84 has been removed from the valve 30, itcannot be reengaged with the valve 30. Thus, a missing or stripped cap84 indicates that the cap 84 has been tampered with. It is to beunderstood that if desired, a new cap (not shown) that is in allessential respects identical to the cap 84 can be engaged with the valve30, although the new cap can be a different color than the cap 84.

In the operation of the bag 10, reference is made to FIG. 1. With thebag 10 initially full of fluid to be infused into the patient 14, thevalves 30, 42 are closed to prevent fluid flow through the ports 28, 36.In other words, the valve members 54, 72 are biased into their normallyclosed configurations. Also, the membrane within the conventional port24 prevents fluid flow through the conventional port 24.

A path for fluid communication can be established through any one of theports 24, 28, 36 by advancing an appropriate connector into theparticular port. For example, fluid 12 from the bag 10 can be infusedinto the patient 14 by advancing a blunt spike (not shown) into thespikeless/needleless port 28. Alternatively, fluid can be added to orextracted from the bag 10 by advancing the end 34 of the needlelesssyringe 32 into the port 28 and operating the plunger of the syringe 32to inject fluid into the bag 10.

More particularly, as described above, the needleless syringe 32 issufficiently advanced into the spikeless/needleless port 28 (and thevalve 30) to open the valve 30. Fluid 12 can then be injected into orextracted from the IV bag 10 through the spikeless/needleless port 28.

Similarly, the conventional spike 22 can be advanced into theconventional port 24 until the spike 22 pierces the membrane within theport 24. This establishes a path for fluid flow through the port 24,spike 22 and IV line 16 into the patient 14. This fluid flow can beeffected by gravity drain or by engaging a peristaltic pump (not shown)with the IV line 16 and pumping fluid 12 into the patient 14.

Further, fluid can be injected or extracted from the IV bag 10 byengaging a needleless syringe with the belly button port 36 andappropriately operating the plunger of the syringe. More specifically,using the belly button port 36 as an example, the connector portion ofthe syringe can be advanced into the valve 42 to open the valve 42, andthe plunger of the syringe then manipulated as appropriate to infuse orextract fluid into the bag 10. The skilled artisan will appreciate thatthe belly button port 36 can be used as another site to piggy back acontainer using a Luer fitting.

When it is no longer necessary to infuse fluid into the bag 10 throughthe spikeless/needleless port 28, the needleless syringe 32 is simplyretracted from the spikeless/needleless port 28. This causes theresilient valve member 54 to resume its normally closed position tothereby block fluid flow through the spikeless/needleless port 28. Also,after fluid has been infused or extracted as appropriate from the bag 10through the belly button port 36, the needleless syringe is simplyretracted from the valve 42. This causes the resilient valve member 72to resume its normally closed configuration, thereby preventing fluidflow through the bellow button port 36. FIG. 1A shows that a glass vial200 can have a needleless port 202. A valve 204 which is in allessential respects identical to the valve 30 can be positioned in theport 202, to selectively establish a needleless connector through whichfluid can pass into or out of the vial 200.

Now referring to FIGS. 5-11, several embodiments of liquid medicamentbags in accordance with the present invention are shown. FIG. 5 showsthat a liquid medicament bag 300 has a first multi-laminate side 302, asecond multi-laminate side 304, and a seam 306 that is established atthe juncture of the sides 302, 304. Thus, the sides 302, 304 with seam306 establish a container of the type well-known in the art for holding,e.g., liquid medicament, cell culture, and other biotech fluids. Theskilled artisan will accordingly appreciate that the material andthickness of the laminated layers are selected for strength, punctureresistance, gas permeability, and compatibility with the fluid containedin the bag 300. For example, FIG. 6 shows that the side 302 has twolayers 302a, 302b. It is to be appreciated that the side 302 can haveadditional layers, if desired.

A rigid plastic valve assembly 308 is fixedly positioned on the seam 306during manufacture by means well-known in the art, e.g., by rf sealing,spin welding, or ultrasonic welding, and the sides 302, 304 of the bag300 are likewise connected, as indicated by a bond line 303. Theassembly 308 in the perspective view shown has a catenary shape whenlooked at from above.

FIGS. 6 and 7 show that the valve assembly 308 is "H"-shaped intransverse cross-section, and has first and second openings 310, 312which are established by flanges 310a, 310b. As shown, the flanges 310a,310b are bonded to the sides 304, 302, respectively, of the bag 300. Afirst reflex valve 314 is positioned in the first opening 310 and asecond reflex valve 316 is positioned in the second opening 312.

The first valve 314 is in all essential respects identical inconstruction to the valve 30 valve member disclosed above, except thatthe first valve 314 has grooves 315 formed in place of the protrusions42a shown in FIGS. 2A and 2B. It is to be understood that the grooves315 fulfill the same function as the protrusions 42a, i.e., the grooves315 prevent a vacuum lock from being established between a valve member317 and a valve body 319.

As shown best in FIG. 7, the second valve 316 also is identical to thevalve 30, except that the second valve 316 has a male valve element 318.More particularly, the male valve element 318 has a cylindrical skirt320 and a contact surface, preferably a shaped head 322 which extendsradially outwardly from the skirt 320. Alternatively, the valve element318 can have a non-rounded shape.

As shown, the second valve 316 is configured as a male luer fitting.Consequently, a female luer fitting 324 (FIG. 8) can be engaged with thevalve 316 such that a tapered inner surface 326 of the female luerfitting 324 urges against the head 322 to move the second valve 316 tothe open configuration.

While FIGS. 6 and 7 show a valve assembly 308 having two valves 314, 316positioned therein, it is to be understood that the assembly 308 canhave one or more openings, and that one or more of the openings can havea piercable membrane positioned therein, if desired. It is to be furtherunderstood that the male valve 316 can be used in place of the valvespreviously valve member losed, e.g., the male valve 316 can be used inplace of the valve 30 shown in FIGS. 2A and 2B.

FIG. 9 shows that a valve assembly, generally designated 330, can have aconfiguration familiarly referred to as a "wedge" configuration.Specifically, in the view shown in FIG. 9, two engagement flanges 336,338 depend downwardly from a bottom surface 340 of the assembly 330. Itis to be understood that in accordance with the present invention, theflanges 336, 338 are positioned between the sides of a liquid medicamentbag, i.e., in the seam of the bag, and are connected thereto by meanswell-known in the art. Like the valve assembly 308 shown in FIGS. 5-8,the valve assembly 330 has two or more reflex valves 342, 344 disposedin respective openings formed by the assembly 330.

FIG. 10 shows that a valve assembly 346 has a gently curved saddle shapebottom surface 348 for conforming to a bag 350. The assembly 346 is andattached to the bag 350 by means well-known in the art, e.g., solventbonding, rf sealing, heat staking, or ultrasonic welding. Like theassemblies 308, 330 shown in FIGS. 5-9, the assembly 346 shown in FIG.10 has two or more valves 352, 354. Also, each valve 352, 354 can have arespective tamper-resistant cap 356, 358 which is configured to engage aluer fitting. The caps 356, 358 can have a well-known configuration forresisting tampering, e.g., the caps 356, 358 can have plastic ratchetthreads which strip during removal of the cap 356, 358 from itsassociated valve 352, 354.

FIG. 11 shows a valve assembly, generally designated 360, which has asocalled boat shape, and is accordingly referred to in the artfamiliarly as a "boat". The assembly 360 also has two openings 362, 364and two valves 366, 368 respectively positioned in the openings 362,364. The Valves 366, 368 can be female or male valves. In the embodimentshown, th& valve 366 is a male valve configured like the valve 316 shownin FIGS. 7 and 8, while the valve 368 is a female valve configured likethe valve 30 shown in FIGS. 2A and 2B.

As can be appreciated in reference to FIG. 11, the assembly 360 has ahull surface 370 which is generally shaped like the gently rounded hullof a boat, and which consequently can be positioned between the junctureof two sides of a bag 372, and then attached to the bag by meanswell-known in the art. In other words, the hull surface 370 of theassembly 360 can be positioned in the seam of a liquid medicament bag.

In addition to the openings valve member discussed above, the assemblies308, 330, 360 can have additional openings (not shown) which can beblocked by respective reflex valves or by pierceable membranes.

FIGS. 12 and 13 show multi-layer medicament bags having multipleindividual tubular connectors for receiving associated valves. Morespecifically, FIG. 12 shows a bag 361 which has a first tubularconnector 363 and a second tubular connector 365. The first tubularconnector 363 includes a hollow cylindrical tube 367 which is bonded tothe bag 360 by means well-known in the art.

A hollow male luer connector 369 is closely received in the tube 366,and a female luer fitting 373 can be engaged with the male luerconnector 369. A valve 371 which is in all essential respects identicalto the valve 316 shown in FIG. 7 is bonded to the female luer fitting373.

Likewise, the second tubular connector 365 includes a hollow cylindricaltube 374 which is bonded to the bag 361 by means well-known in the art.A hollow female luer connector 376 is closely received in the tube 374,and a male luer fitting 378 can be engaged with the female luerconnector 376. A valve 380 which is in all essential respects identicalto the valve 314 shown in FIG. 6 is bonded to the male luer fitting 378.IV lines or other components, e.g., spikes and drip chambers (not shown)having luer fittings can be engaged with the valves 371, 380 toselectively establish fluid flow through the connectors 363, 365 inaccordance with the principles set forth above.

FIG. 13 shows that a multi-layer medicament bag 382 has a plurality ofresilient plastic tubular connectors 384, 386. The connector 384 canclosely receive a valve 388 which is in all essential respects identicalto the valve 28 shown in FIGS. 2A and 2B. If desired, the valve 388 canbe bonded to the connector 384.

FIG. 13 also shows that an intermediate connector tube 390 can be bondedto the connector 386, and a hollow Y-fitting 392 in turn bonded to theintermediate connector tube 390. If desired, an extender tube 393 can beconnected to a first leg tube 392a of the Y-fitting 392, and a firstluer bulkhead fitting 394 can be advanced into the extender tube 393. Asecond luer bulkhead fitting 396 can be advanced into a second leg tube392b of the Y-fitting 392 or extension tubes (not shown) that areconnected to the second leg tube 392b.

Each of the luer bulkhead fittings 394, 396 has respective ratchet rings394a, 396a which are configured as shown for permitting the luerbulkhead fittings 394, 396 to be advanced into their respective tubes393, 392b, and for preventing the luer bulkhead fittings 394, 396 frombeing easily retracted from their respective tubes 393, 392b. Ifdesired, the luer bulkhead fitting 394 can also include a locking ringassembly, generally designated 398, which includes a threaded body 400,a locking ring 402 threadably engaged with the body 400, and a backingring 404. The luer bulkhead fittings 394, 396 can advantageously besimilar to any one of the luer bulkhead fittings made by Value Plastics,Inc. of Fort Collins, Colo.

A male reflex valve 406 which is in all essential respects identical tothe valve 316 shown in FIG. 7 is bonded by means well-known in the artto the first bulkhead luer fitting 394. Likewise, a female reflex valve408 which is in all essential respects identical to the valve 314 shownin FIG. 6 is bonded by means well-known in the art to the secondbulkhead luer fitting 396. IV lines or other components, e.g., spikesand drip chambers (not shown) having luer fittings can be engaged withthe valves 388, 406, 408 to selectively establish fluid flow through theconnectors 384 and Y-leg tubes 392a, 392b (and extension tubes thereof,e.g., the tube 393) in accordance with the principles set forth above.

FIG. 14 shows a valve 450 which is a male reflux valve configured likethe valve 316 shown in FIG. 7. Accordingly, the valve 450 includes amale Luer connector 452. In accordance with principles well known in theart, the male Luer connector 452 is formed with an outer frusto-conicalwall 454 which tapers slightly radially inwardly from a proximal end 456to a distal end 458 of the connector 452.

As shown, the valve 450 is bonded to an intravenous (IV) component 460.It is to be understood that the valve 450 can be attached to thecomponent 460 by means well known in the art, e.g., solvent bonding, RFsealing, heat staking, spin welding, or sonic welding. As will be morefully valve member disclosed below, the IV component 460 can be any IVcomponent for which it is desired to selectively establish fluidcommunication into or out of. For example, the IV component 460 can bean IV container such as a bag, or a syringe, spike, fluid line, dripchamber, connector fitting, filter, stopcock, Burette chamber, oradapter fitting. Consequently, the skilled artisan will appreciate thatthe valve 450 can be used in a large number of applications, includingIV container devices and sets, enteral feeding, other biotechnologyapplications, other medical applications including cardiovascular,urology, anesthesiology and chemotherapy.

FIG. 15 shows a male reflux valve 462 which is bonded to a female Luerfitting 464. A fluid passageway 466 is established by the valve 462 andthe female Luer fitting 464, and fluid communication through the fluidpassageway 466 is selectively established by manipulating a male valveelement 468 of the valve 462 as described previously. It is to beunderstood that the female Luer fitting 464 can include a female refluxvalve as described previously.

FIG. 16 shows a male reflux valve 470 which is bonded to a connector472, and the connector 472 has cylindrical walls 474, 476. The externalwalls 476 or the internal walls 474 of the connector 472 can in turn bebonded to another IV component. The reflux valve 470 selectivelyestablishes fluid flow through the fluid passageway which is establishedby the connector 472.

FIG. 17 shows a male reflux valve 478 which is bonded to a check valve480, and the check valve 480 is in turn bonded to an IV component 482.As shown, the male reflux valve includes a male valve element 484, areflux disk 486, a support element 488 for supporting the reflux disk486 in the center thereof, and a retainer element 490. The check valve480 includes a check valve body 492 and a check valve disk 494. Also, acheck valve support element 496 is provided for supporting the checkvalve disk 494 in the center thereof. It can be appreciated in referenceto FIG. 17 that the support element 488 functions as a retainer elementfor the check valve disk 494.

It will be further appreciated that the check valve disk 494 permitsfluid flow through a fluid passageway 498 only in the directionindicated by the arrow 500 and substantially prevents fluid flow in adirection opposite the arrow 500. This is true regardless of whether themale valve element 484 has been urged into the reflux disk 486 to formthe disk. Accordingly, the combination of structure shown in FIG. 17results in a modified check valve in which fluid flow only in thedirection of the arrow 500 is permitted, only when the male valveelement 484 is urged against the reflux disk 486. It is to be understoodthat in some applications, the male reflux valve 478 can be replaced bya female reflux valve (not shown).

FIG. 18 shows a male reflux valve 502 which is engaged with a barbedconnector 504 that is formed with a plurality of frusto-conical shapedbarbs 506, with the barbs being configured for securely engaging thelumen of another IV component (not shown), such as an IV line. Otherbarb shapes may also be used. The male reflux valve 502, in accordancewith the valve member discussion above, selectively establishes fluidcommunication through a cylindrical passageway 508 which is establishedby the barbed connector 504.

FIG. 19 shows a male reflux valve 510 which is connected to a steppedconnector 512 having a plurality of steps 514, with the steps beingconfigured for securely engaging the lumen of another IV component (notshown), such as an IV line. The reflux valve 510 selectively establishesfluid flow through a cylindrical fluid passageway 516 which isestablished by the stepped connector 512. It is to be understood thatthe connector 512 can have a continuously tapered outer wall instead ofthe steps shown.

FIG. 20 shows a male reflux valve, generally designated 518, whichincludes a male valve element or female valve element 520 and a valvebody 522. As shown, the valve element 520 includes a contact flange 524defining a flat contact surface 526 and a body surface 528 that isopposed to the contact surface 526. As shown in FIG. 20, the bodysurface 528 defines an angle αrelative to the contact surface 526. Morespecifically, the body surface 528 defines an angle α relative to thecontact surface 526 of between about 5° and 75°.

Likewise, the valve body 522 is formed with an abutment surface 530which is generally parallel to the body surface 528 of the contactflange 524. It is to be understood that the abutment surface 530 andbody surface 528 interlock with each other to more securely hold thevalve element 520 within the valve body 522.

FIG. 21 shows a male reflux valve 534 which is connected to a connector536 for selectively establishing fluid flow through a cylindrical fluidpassageway 538 defined by the connector 536. As shown, the connector 536has a tapered segment 540 and a threaded segment 542 for engaging acomplementarily threaded IV component.

FIG. 22 shows a male reflux valve 544 which is disposed in a port 546 ofa so-called "T"-site connector 548. The T-site connector 548 defines amain fluid passageway 550 and a secondary fluid passageway 552, and themale reflux valve 544 can be manipulated as described above toselectively permit fluid communication through the secondary fluidpassageway 552 of the T-site connector 548.

FIG. 23 shows a male reflux valve 554 which is disposed in a port 556 ofa so-called "Y"-site connector 558. As shown, the Y-site connector 558defines a main cylindrical fluid passageway 560 and a secondary fluidpassageway 562. The valve 554 can be operated as valve member disclosedabove to selectively block fluid communication through the secondarypassageway 562 of the Y-site connector 558.

FIG. 24 is an exploded view of a male reflux valve, generally designated564, and a female reflux valve, generally designated 566. As valvemember disclosed above, the male reflux valve 564 includes a valve body568 which is configured as a male Luer fitting, while the female refluxvalve 566 includes a valve body 570 generally configured as a femaleLuer fitting.

Each of the valves 564, 566 includes its own disk, represented by thesingle disk 572 shown in FIG. 24. Either of the valves 564, 566 can beengaged in either one of the ports 574, 576 of respective syringes 578,580. The skilled artisan will appreciate in reference to FIG. 24 thatthe syringe 578 is a shaft-style syringe and accordingly includes ashaft 582 connected to a proximal plunger 583. On the other hand, thesyringe 580 is a syringe of the style made by Smith and Nephew, andaccordingly has no shaft connected to the plunger. In accordance withprinciples valve member disclosed above, fluid communication through theports 574, 576 of the syringes 578, 580 can be selectively establishedby either one of the valves 564, 566.

FIG. 25 shows a plurality of valving arrangements which can be used toselectively block fluid communication through the ports of a dripchamber 584 and a Burette chamber 586. More specifically, the dripchamber 584 has a port 588 which is established by an outwardlyprotruding cylindrical wall 590. The drip chamber 584 further includes acone or sock filter 592 which covers an outlet port 594. It is to beunderstood that the filter 592 can have other configurations known inthe art, e.g. as shown in FIG. 25.

The inlet port 588 of the drip chamber 584 can receive one of aplurality of valves for selectively blocking fluid communication throughthe port 588. More specifically, a first male reflux valve 596 can havea bonding segment 598 which is bonded to the walls 590 of the inlet port588. It is to be understood that the male reflux valve 596, like theother male reflux valves valve member disclosed herein, is substantiallyidentical in configuration to the reflux valve 316 shown in FIG. 7.

Alternatively, a first female reflux valve 600 having an engagementsegment 602 can be disposed in the inlet port 588 of the syringe 584,with the engagement segment 602 being bonded to the walls 590 of theinlet port 588. It is to be understood that the first female refluxvalve 600 is substantially identical in configuration to the otherfemale reflux valves previously described, e.g. the valve 30 shown inFIG. 1. Furthermore, a second female reflux valve 604 can be disposed inthe port 588 of the drip chamber 584 to selectively establish fluidcommunication through the inlet port 588. The second female reflux valve604 may be configured differently than the first female valve 600, e.g.the second female valve 604 may be one of the IV valves made by Claveyor Halkey-Roberts.

Still referring to FIG. 25, the Burette chamber 586 has a first inletport 606 which is defined by an outwardly protruding cylindrical wall608. It can be appreciated in reference to FIG. 25 that any one of thevalves 596, 600, 604 may be disposed in the first inlet port 606 of theBurette chamber 586 to selectively block fluid communicationtherethrough in accordance with principles valve member disclosed above.Furthermore, FIG. 25 shows that the Burette chamber 586 has second andthird inlet ports 610, 612 and a fourth inlet port 614. As shown, thefourth inlet port 614 includes a support element 616, the function ofwhich has been described previously in relation to supporting adeformable valve member of the present invention.

Accordingly, the support element 616 supports a deformable resilientdisk 618 which can be the disk of a male reflux valve 620 or a femalereflux valve 622 under the principles valve member disclosed previously.Thus, it will be understood that the fourth inlet port 614 of theBurette chamber 586 can be configured as a portion of the valve assemblyfor either one of the valves 620, 622.

Now referring to FIG. 26, a filter chamber, generally designated 624,has a first port 626, a second port 628, and a chamber 630 formedtherebetween. As shown, the chamber 630 is catenary-shaped incross-section. Also, a disk-shaped filter 632 is disposed in thecatenary-shaped chamber 630.

A reflux valve in accordance to the present invention can be disposed ineither one or both of the ports 626, 628. In the embodiment shown inFIG. 26, a male reflux valve 634 is disposed in the second port 628,while a female reflex valve 636 is disposed in the first fluid port 626.In accordance with the principles of the present invention valve memberdisclosed above, either one or both of the reflux valves 634, 636 may beoperated to selectively establish fluid communication through itsrespective port 628, 626 and into the catenary-shaped chamber 630.

FIG. 27 shows an IV stopcock, generally designated 638. In accordancewith principles well known in the art, the stopcock 638 includes acentral fluid passageway that is covered by a cover plate 640, and anoperating hand wheel 642. Additionally, the stopcock 638 can include atleast two ports, and can include additional ports. In the embodimentshown in FIG. 27, the stopcock 638 includes first, second and thirdports 644, 646, 648. A respective reflux valve is disposed in each oneof the ports 644, 646, 648 to selectively establish fluid communicationthrough the port. More particularly, a first female reflux valve 650 isdisposed in the first port 644, a male reflux valve 652 is disposed inthe second port 646, and a second female reflux valve 654 is disposed inthe third port 648. The first and second female reflux valves 650, 654are in all essential respects identical in configuration to the refluxvalve 30 shown in FIG. 1, while the male reflux valve 652 is in allessential respects identical to the male reflux valve 316 shown in FIG.7. It is to be further understood that one or more of the ports 644,646, 648 may not include a reflux valve, and that for the embodimentshown in FIG. 27, i.e. a stopcock 638 having three ports, one of theports will contain a male reflux valve while the remaining ports willcontain female reflux valves.

Now referring to FIG. 28, the skilled artisan will appreciate that thereflux valves of the present invention can be disposed in various typesof spikes for selectively establishing fluid communication through thespikes. More particularly, a first female reflux valve 656 can bedisposed in an outlet port 658 of a nonvented spike 660. Also, the firstfemale reflux valve 656 can be disposed in the outlet port 662 of afirst vented spike 664. Moreover, the first female reflux valve 656 canbe disposed in an outlet port 666 of a second type of vented spike 668.In accordance with the present invention, the first female reflux valve656 is configured substantially identically to the reflux valve 30 shownin FIG. 1 and can be fixedly engaged in any one of the spikes 660, 664,668 by means well known in the art valve member disclosed above.

Furthermore, a male reflux valve 670 which is in all essential respectsidentical in configuration to the reflux valve 316 shown in FIG. 7 canbe engaged with any one of the outlet ports 658, 662, 666 of therespective spikes 660, 664, 668. Additionally, a second female refluxvalve 672 can be engaged with any one of the ports 658, 662, 666 of therespective spikes 660, 664, 668. As intended by the present invention,the second female reflux valve 672 is substantially identical to thefemale reflux valve 604 shown in FIG. 25.

Now referring to FIG. 29, a novel multiport IV valve of the presentinvention, generally designated 674, can be seen. As shown, themultiport valve 674 includes a first port 676 which is generallycylindrically shaped, and a second port 678 which is also generallycylindrically shaped and is configured as a female Luer fitting. As canbe appreciated in reference to

FIG. 29, the first and second ports 676, 678 are coaxial and establish amain fluid passageway therebetween. A first male Luer valve 680 isfixedly engaged with the first port 676 for selectively blocking fluidcommunication therethrough.

FIG. 29 additionally shows that the multiport valve 674 includes third,fourth, fifth and sixth ports 682, 684, 686, 688, all of which aregenerally cylindrically shaped. As shown, the third and fifth ports 682,686 are coaxial with each other. Likewise, the fourth and sixth ports684, 688 are coaxial with each other. Each of the third through sixthports 682, 684, 686, 688 defines a respective fluid pathway, and fluidcommunication through the fluid pathway can be selectively establishedor otherwise effected as valve member disclosed below.

For example, a female reflux valve 690 can be disposed in the thirdfluid port 682 for selectively establishing fluid communication throughthe port 682 and into the main fluid passageway 679 in accordance withprinciples valve member disclosed previously. Moreover, a combinationmale reflux valve-check valve 692, 694, which is substantially identicalto the valve 478, 480 shown in FIG. 17, can be disposed in the fourthfluid inlet port 684 of the multiport valve 674. If desired, the malereflux valve 692 can be replaced with a female reflux valve (not shown)which is substantially identical to the female reflux valve 30 shown inFIG. 1.

Additionally, fluid communication through the fifth inlet port 686 canbe permanently blocked if desired by bonding a plug 696 within the port686 by means well known in the art. Alternatively, the fifth fluid inletport 686 can hold a fluid filter, e.g. a filter 698. As shown, thefilter 698 includes a filter element 700 having a membrane 702 throughwhich air can pass. The filter 698 also includes a plug element 704which engages filter element 700 and which holds the filter element 700within the sixth fluid port 686.

Now referring to FIG. 30, an inline multiport valve is shown, generallyshown 710. As shown, the valve 710 includes an elongated, generallyparallelepiped-shaped valve body 712 that is formed with a fluid inletport 714 and a fluid outlet port 716. The fluid inlet port 714 isconfigured as a female Luer fitting and the fluid outlet port 716 isconfigured as a male Luer fitting. A generally cylindrical main fluidpassageway 718 is established through the valve body 712 between theports 714, 716.

Additionally, the valve body 712 is formed with two to six fluid inletports. In the embodiment shown in FIG. 30, the valve body 712 includesfirst through third fluid inlet ports 720, 722, 724. One or more refluxvalves may be positioned in the ports 720, 722, 724 to selectivelyestablish fluid communication therethrough. More particularly, a firstmale reflux valve 726 is positioned in the first port 724, a second malereflux valve 728 is positioned in the second port 726, and a third malereflux valve 730 is positioned in the third port 724. The first malereflux valve 726 can include a check valve 732 having a deformable valvemember 734 to establish a reflux-check valve like the structure shown inFIG. 17.

When the inline multiport valve 710 includes only three ports, a solid,continuous parallelepiped-shaped bottom plate 735 is rf sealed orultrasonically welded to the valve body 712 opposite the first throughthird ports 720, 722, 724. On the other hand, the inline multiport valve710 may include additional ports, in which case the bottom plate 735 isreplaced with a port plate 737 which is formed with fourth through sixthports 736, 738, 740. A male reflux valve 742 can be positioned in thesixth port 740, a female reflux valve 744 can be positioned in the fifthport 738, and a filter 746 which is similar to the filter 698 shown inFIG. 29 can be positioned in the fourth port 736. The fourth port 736can include the mounting bracket, reflux valves, filter, plug, and checkvalve options shown in FIG. 29.

FIG. 31 shows that a male reflux valve, generally designated 750, caninclude a male valve element 752 and a frusto-conical shaped valve body754, which is formed with a tapered wall 755. It is to be understoodthat the valve body 754 is configured as an adapter fitting, e.g., aLuer catheter adapter, a 9/32 adapter, or 3/16 adapter, forinterconnecting two IV components having inside diameters differing fromeach other.

The valve 750 has a port 756 defined by an inner cylindrical wall 758which is surrounded by an outer cylindrical wall 760. Either of thewalls 758, 760 can be bonded to an IV component (not shown) by meanswell-known in the art.

FIG. 32 shows a valve, generally designated 762, having a frusto-conicalshaped body 764 formed with a tapered wall 765 for configuring the valve762 as an enteral feeding adapter. The valve 762 also includes a hollowcylindrical valve element 766 having an outer wall 766a which taperstoward an inner wall 766b near a distal end 766c of the element 766. Forpurposes of the present invention, the valve element 766 includes askirt 766d disposed in the valve body 764 and an engagement surface 766ethat extends beyond the fluid passageway established by the valve body764. Also, the valve 762 includes a deformable resilient valve member768, and the valve element 766 can be urged against the valve member 768to deform the valve member and thereby permit fluid communicationthrough the valve 762.

The valve 762 has a port 770 defined by an inner cylindrical wall 772which is surrounded by an outer cylindrical wall 774. Either of thewalls 772, 774 can be bonded to an IV component (not shown) by meanswell-known in the art.

While the particular needleless valve for use with intravenous infusioncomponents as herein shown and described in detail is fully capable ofattaining the objects stated above, it is to be understood that it isbut the presently preferred embodiments of the present invention, andthat the scope of the present invention is accordingly to be ignited bynothing other than the appended claims.

I claim:
 1. An IV port, comprising:an IV container selected from thegroup of containers consisting of flexible IV bags and rigid IVcontainer; at least one port body extending from the IV container; avalve body operably engaged within the port body, the valve bodydefining a fluid passageway for permitting fluid flow into and out ofthe IV container, the valve body being configured as a female luerfitting; and a valve member positioned in the valve body for selectivelyblocking fluid through the valve body, the valve member defining anouter periphery that is uninterrupted within the periphery, the valvemember being disposed in the valve body and biased to a closedconfiguration, wherein a passageway for fluid communication is notestablished through the valve body, the valve member being movable to anopen configuration when a mating component is engaged, wherein two-wayfluid communication through the valve body is permitted.
 2. The port ofclaim 1, wherein the port body is configured in the shape referred to asa "Wedge" port.
 3. The port of claim 1, wherein the port body isconfigured in the shape referred to as a "Boat port".
 4. The port ofclaim 1, wherein the port body is configured in the shape referred to asa "Saddle" port.
 5. The port of claim 1, wherein the port body isconfigured in the shape referred to as a "Belly Button" port.
 6. Theport of claim 1, wherein the port body is configured as a check valve,in which a resilient valve member biased to the first configuration,wherein a passageway for fluid communication is not established throughthe valve body, the member being deformable to a second configuration,wherein fluid communication through the body is permitted.
 7. The portof claim 1, wherein the valve body has a continuous smooth outer surfacedefining a periphery, the valve body being in contact with the IVcontainer entirely around the periphery to facilitate leak-freeengagement between the bag and the valve body.
 8. The port of claim 7,wherein the IV container is a bag, and the port further comprises a tubedisposed in the bag, the valve body being received in the tube forfacilitating leak-free engagement between the bag and the valve body. 9.A port comprising:a container selected from the group of containersconsisting of flexible IV bags and rigid IV containers; at least oneport body extending from the IV container, the port body configured as awedge port, boat port, or a saddle port; a valve body operably engagedwithin the port body, the valve body defining a fluid passageway forpermitting fluid flow into and out of the IV container, the valve bodybeing configured as a luer fitting; a valve member positioned in thevalve body for selecting blocking fluid through the valve body, thevalve member defining an outer periphery, the valve member beingdisposed in the valve body and biased to a closed configuration, whereina passageway for fluid communication is not established through thevalve body, the valve member being movable to an open configuration whenthe leur is engaged, wherein two-way fluid communication through thevalve body is permitted.
 10. The port of claim 9 wherein the luer isconfigured as a female luer.
 11. The port of claim 9 wherein the luer isconfigured as a male luer, with a male valve element disposed in thevalve body and defining an engagement surface extending outwardly beyondthe valve body for contacting a connector to cause the valve element tomove the valve member to an open configuration.
 12. A port comprising:acontainer selected from the group of containers consisting of flexibleIV bags and rigid IV containers; a valve body defining a port forpermitting fluid flow into and out of the IV container, the valve bodybeing configured as a luer fitting; at least one port body configured asa belly button port; a valve member positioned in the valve body forselectively blocking fluid flow through the valve body, the valve memberdefining an outer periphery that is uninterrupted within the periphery,the valve member being disposed in the valve body and biased to a closedconfiguration, wherein a passageway for fluid communication is notestablished through the valve body, the valve member being movable to anopen configuration when the luer is engaged, wherein two-way fluidcommunication through the valve body is permitted.
 13. A port accordingto claim 12, wherein the luer is configured as a male luer.